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Clinical trial with authentic recombinant somatropin in Japan.

Abstract
Recombinant somatropin, produced by recombinant DNA technology, was administered by injection in daily doses of 8 IU to six healthy young volunteers. Daily injection for 4 days did not cause any significant change in the results of physical examination, blood count or urinalysis. Non-esterified fatty acid levels increased significantly from 0.45 +/- 0.16 to 1.08 +/- 0.12 mEq/litre (mean +/- SEM) at 4 hours after the first injection (p less than 0.001). Plasma IGF-1 levels increased from 0.80 +/- 0.14 units/ml to 1.72 +/- 0.50, 3.22 +/- 1.02, 3.17 +/- 1.20 and 3.63 +/- 0.78 units/ml at 24 hours after each daily injection for 4 days (p less than 0.001). Plasma hGH reached peak levels at 3 hours after intramuscular injection of recombinant somatropin, 4 IU, and this peak value was 57.3 +/- 2.8 ng/ml. A total of 21 patients with pituitary dwarfism were also treated with recombinant somatropin for 6 months at a dose of 0.5 IU/kg/week. Their heights increased by 2.2-5.0 cm during the 6 months of treatment, which was calculated to be equivalent to 4.4-10.0 cm/year with a mean growth rate of 7.4 +/- 0.4 cm/year. Anti-hGH antibody with a titre of 10 was observed in two patients at the end of 6 months of treatment.
AuthorsK Takano, K Shizume, I Hibi, A Okuno, H Nakajima, S Suwa, T Nogawa, T Kondo, T Momoi, N Iwatani
JournalActa paediatrica Scandinavica. Supplement (Acta Paediatr Scand Suppl) Vol. 331 Pg. 18-24 ( 1987) ISSN: 0300-8843 [Print] Sweden
PMID3300151 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies
  • Fatty Acids, Nonesterified
  • Recombinant Proteins
  • Insulin-Like Growth Factor I
  • Growth Hormone
Topics
  • Adolescent
  • Adult
  • Age Determination by Skeleton
  • Antibodies (analysis)
  • Body Height
  • Child
  • Clinical Trials as Topic
  • Dwarfism, Pituitary (drug therapy)
  • Fatty Acids, Nonesterified (blood)
  • Female
  • Growth Hormone (blood, deficiency, immunology, therapeutic use)
  • Humans
  • Insulin-Like Growth Factor I (blood)
  • Japan
  • Kinetics
  • Male
  • Recombinant Proteins (blood, therapeutic use)

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